Donor Immune Cell Therapy for Acute Myeloid Leukemia

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Biological: infusion of natural killer cells

• Registration Number: NCT05333705
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

This study aims to introduce a new technology of donor NK cell infusion. NK cells defend against viruses and cancer cells in vivo whereas this effect declines in patiens with tumors. In this study, NK cells will be separated from donated peripheral blood or umbilical cord blood. Eligible NK cells will be infused to patients with Acute myeloid leukemia (AML). This new therapy will probably induce their sustained remission and reduce recurrences.

Detailed Description

Primary end point:

To determine the rate of overall survival at 2 years of Interventional cohort

Secondary end point:

To determine the cumulative incidence of relapse at 2 years. To determine the rate of disease-free survival at 2 years. Describe the safety and toxicity of donor NK cell infusion.

Study Design:

This study is a phase I clinical trial. 15 eligible AML patients will be enrolled sequentially to receive detached NK cells product during induction or consolidation therapy. Refractory or relapsed patients and patients who achieved complete remission (CR) after induction therapy are included. They will receive anthracycline-based chemotherapy according to NCCN guidelines. At the same time, Cultured NK cells will be infused into patients after chemotherapy. Anti-allergic therapy and prophylaxis of graft versus host disease (GVHD) will be given before infusion. Treatment effect will be measured and adverse effect will be treated and documented after intervention.

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-11
• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-04-17
• Last Update Submitted: 2022-04-17
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19
• Primary Completion: 2024-07-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients must have been diagnosed as acute myeloid leukemia in accordance with "Chinese Diagnosis and Treatment Guidelines of AML". Those who achieved CR after chemotherapy are mainly included. Refractory/relapsed AML can also be enrolled.
• Patients with normal heart function (ejection fraction ≥ 50%), normal liver function(ALT and AST ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value) and normal renal function with blood creatinine ≤ 3.0 mg/dL (≤ 260 µmol /L) can be enrolled.
• Patients will be required to sign an informed consent.

Exclusion Criteria

• Patients with severe infection or other malignant tumors.
• Women during pregnancy or lactation.
• Other patients deemed unsuitable by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
immune cell arm	infusion of natural killer cells	Umbilical cord blood or donated peripheral blood of healthy donors were collected and NK cells were cultured. NK cell production will be infused after chemotherapy.

Primary Outcome Measures

Name	Time	Method
hematological response rate	up to 2 years, from treatment begining to death	Hematological Complete Remission (HCR): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x10\^9/L; platelet count \>100x10\^9/L.
Overall survival	Up to 2 years after beginning treatment	Overall survival (OS) is measured from the date of first infusion of NK cells to the date of death from any cause; patients not known to have died at last follow up are censored on the date they were last known to be alive.

Secondary Outcome Measures

Name	Time	Method
Disease free survival (DFS)	Up to 2 years after beginning treatment	Disease free survival (DFS) is defined as the time from the date of first infusion of NK cells to the date of relapse or death as a result of any cause.
Cumulative incidence of relapse	Up to 2 years after beginning treatment	Relapse was defined as the recurrence of above 5%bone marrow blasts and the reappearance of blasts in the blood or the development of extramedullary disease infiltrates at any site.
Incidence of adverse effects	Up to 2 years after beginning treatment	Toxic effects were graded according to the National Cancer Institute's Common Toxicity Criteria.

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China